It has been known heretofore to administer certain types of stem cells to humans and to animals in order to achieve a therapeutic end. Much of this has been done with stem cells from adults, such as those found in adult bone marrow, especially for the repopulation of depopulated interosseous spaces, which attend aggressive chemotherapy or radiation therapy, e.g., for treatment of certain cancers. Indeed, such cytotherapy has become relatively widespread and has achieved a level of success despite limitations including the lack of standardization as to cell numbers and types.
Many of these therapeutic regimes employ relatively mature cellular preparations, e.g. bone marrow. While these have a level of therapeutic potential, such cells possess quite a large number of surface antigens and require immunosupression attendant to administration. Additionally, most cells extracted from adult bone marrow are limited in the types of cells into which they can differentiate. There have been a number of reports that have indicated that most stem cells isolated from adult bone marrow are only able to differentiate into blood cells. While this is useful for the treatment of blood related diseases, e.g., leukemia, these cells are not very useful for treating other types of diseases that are localized to a specific type of tissue or organ. An additional problem with bone marrow preparations is that the process of extracting the marrow is often very painful, and although potential donors can be identified many do not consent to the procedure because of the potential for pain and discomfort.
Recently, cytotherapy employing less mature stem cells, such as, for example, those found in neonatal cord blood, has found some success. However, stem cell preparations from most sources, including from neonatal cord blood, include a diverse population of cells with differing potentials for effective therapy and often do not contain a sufficient number of cells for an optimized therapeutic dose, particularly for an averaged size adult undergoing a transplant for leukemia, for example. It is believed that different scientific and medical groups likely achieve differing preparations with differing characteristics, even when supposedly following the same or similar protocols. Presently, most independent preparations, even those done by the same individual, can have different compositions with the specifics of the compositions undetermined. In short, there is a complete lack of unit to unit reproducibility and little standardization in the cellular units used in transplants.
The foregoing practices can give rise to inconsistent therapeutic outcomes from different research and medical centers and make accurate, statistical analyses for cytotherapeutic procedures difficult or impossible to attain. There is, thus, a long-felt need for improved cytotherapeutic materials and procedures, ones amenable to reproducible outcomes and to scientific analysis. It is also desired to improve specificity of cytotherapeutic treatments and to affect improved efficiencies and outcomes. Importantly, there is also a need for unit to unit reproducibility which may further the ability to collect sufficient data to advance the medical area devoted to cellular therapies. The present invention provides solutions for these and other long-felt needs.